Phase III Trial of Gemcitabine Plus Cisplatin Versus Cisplatin Alone in Patients With Locally Advanced or Metastatic Non–Small-Cell Lung Cancer

摘要: PURPOSE: The Hoosier Oncology Group has previously reported the results of its phase II trial combination cisplatin plus gemcitabine. In that study 27 assessable patients with advanced or metastatic non–small-cell lung cancer (NSCLC), response rate was 33%, a median survival 8.4 months. Based on such favorable results, designed this randomized III gemcitabine compared alone in chemotherapy-naive NSCLC. PATIENTS AND METHODS: Patients were to receive either (100 mg/m2 intravenously day 1 28-day cycle) 1) (1,000 administered days 1, 8, and 15 cycle). RESULTS: From August 1995 February 1997, 522 randomized. Toxicity predominantly hematologic more pronounced arm, grade...